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MDCG Issued Guidance on Transitional Provisions
The Medical Device Coordination Group (MDCG) of the European Commission (EC) issued guidance on certain transitional provisions regarding European Union medical devices regulations. MDCG on Transitional Provisions  ...
EC Clarifies Status of Expert Panels
Expert Panels: Functions and Features According to the new regulatory framework set forth by Medical Device Directive (MDR) and In Vitro Diagnostic Directive (IVDR), special expert panels should be designated to...
FDA’s CDRA Warns About Cybersecurity
FDA’s Center for Devices and Radiological Health (CDRH) holds a meeting to discuss the risks and threats of cybersecurity in medical devices. They describe the unique challenges involved with security and how difficult...